Clinical Impact of Cytokine in Cardiac Surgery

• Conditions: Coronary Disease

• Registration Number: NCT02213939
• Lead Sponsor: University Hospital of Cologne

Brief Summary

Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can cause a systemic inflammatory response syndrome (SIRS) which is associated with increased morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a potential benefit for cardiac surgery patients.

The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the investigators conduct this prospective, observational pilot study to determine the clinical impact of the use of a cytokine adsorbing circuit during CBP.

Detailed Description

Patients, who have an elective myocardial revascularization and give there written consent will be enrolled to the study. Demographic, intraoperative, and postoperative data will be collected prospectively. Furthermore, blood samples (1. before induction of anaesthesia 2. at the end of CPB 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery) will be analyzed.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-12
• Primary Completion: 2017-12
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• • Elective myocardial revascularization

Exclusion Criteria

• Emergency procedures
• Declined informed consent
• Body mass index < 18
• Age < 18 years
• Pregnant women
• Receiving chemotherapy
• Diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
• Receiving antileukocyte drugs
• Receiving TNF-α Blockers
• Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen)
• CRP > 5 mg/dl

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evolution of the inflammatory response	Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day	Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP

Secondary Outcome Measures

Name	Time	Method
Length of ventilation	participants will be followed for the duration of hospital stay, an expected average of 10 days	Length of ventilation (hours)
kidney injury	participants will be followed for the duration of hospital stay, an expected average of 10 days	kidney injury defined as an increase in SCr by ≥1.0 mg/dl (≥26.5 μmol/l) after surgery ; or Increase in SCr to ≥1.5 times baseline, or Urine volume \< 0.5 ml/kg/h for 6 hours.
Length of catecholamine therapy	participants will be followed for the duration of hospital stay, an expected average of 10 days	Length of catecholamine therapy
Length of ICU and hospital stay	participants will be followed for the duration of hospital stay, an expected average of 10 days	Length of ICU and hospital stay
MACCE (mortality; myocardial infarction; cerebrovascular accident)	participants will be followed for the duration of hospital stay, an expected average of 10 days	Mortality measured as any kind of death and myocardial death Myocardial Infarction measured with ECG; CK-MB, cTnT Cerebrovascular accident verified with abnormal cerebral CT scan

Trial Locations

Locations (1)

University Hospital of Cologne; Department of Cardiothoracic Surgery; 🇩🇪 Cologne, Germany